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No enrollment because of war in the study country.
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This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.
This study was terminated - Please see "P04367 - Lebanon"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasonex Nasal Spray | Experimental |
| |
| Placebo Nasal Spray | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate nasal spray | Drug | One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen. | The total duration of therapy is 3 months the follow up period is for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex. | The total duration of therapy is 3 months the follow up period is for 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| placebo nasal spray | Drug | One spray in each nostril once daily for 3 months. |
|
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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